Periimplant Crestal Bone Level ChangesNCT01917305
Influence of Platform-switching on Bone Level Alterations: a 3 Year Randomized Clinical Trial (RCT).
A study testing platform-shifted implant in people with Periimplant Crestal Bone Level Changes, run by Søren Jepsen.
Trial summary
The concept of platform-switching has been introduced to implant dentistry based on clinical observations of reduced periimplant crestal bone loss. However, published available data are controversial and most studies are limited to 12 months. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Periimplant Crestal Bone Level Changes
- What is being tested?
- platform-shifted implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Feb 2007to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- good general health
- edentulous gap in the posterior mandible for placement of 2 implants
- sufficient bone height above the alveolar nerve for placement of implants with a height of 9.5mm
- bone width for placement of implants with diameter of 4mm
- at least 4mm keratinized mucosa
- medium or a thick soft tissue biotype
Who cannot join
- infectious disease
- diabetes or osteopathy
- active periodontitis
- medication influencing bone metabolism
- lactating or pregnant women
About this study
Official title: Influence of Platform-switching on Bone Level Alterations: a 3 Year RCT.
The concept of platform-switching has been introduced to implant dentistry based on clinical observations of reduced periimplant crestal bone loss. However, published available data are controversial and most studies are limited to 12 months. The aim of the present RCT was to test the hypothesis that platform-switching has a positive impact on crestal bone level changes after 3 years.
Read the detailed description
Two implants with a diameter of 4 mm were inserted crestally in the posterior mandible of 25 subjects. After three months of submerged healing, single-tooth crowns were randomly placed, either with (3.3mm platform, test) or without platform-switching (4mm platform, control). Patients were followed up at short intervals for monitoring of healing an oral hygiene. Statistical analysis for the influence of time and platform-type on bone levels employed the Brunner-Langer Model.
- Conditions
- Periimplant Crestal Bone Level Changes
- Being tested
- platform-shifted implant
- Keywords
- Bacteria, bone level, bone loss, dental implants, implant design, platform-shifting, platform-matching
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platform-shifted implantDevice
| Study group | Role | What they receive |
|---|---|---|
| platform-switched implant | Experimental | platform-switched implant Receives: Device: platform-shifted implant |
| platform-matched implant | Active comparator | platform-matched implant Receives: Device: platform-shifted implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of vertical implant bone level
Measured: Implant insertion (baseline), 3 months (reopening), 4 months (crown mounting), 12, 25 and 38 months
Secondary outcomes (3)
probing depths
Measured: 4, 8, 12, 25, 38 months
Bleeding
Measured: baseline, 4, 8, 12, 25, 38 months
Plaque
Measured: baseline, 4, 8, 12, 25, 38 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2013 (estimated)
- Study startFeb 2007
- Primary completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Periimplant Crestal Bone Level ChangesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Søren Jepsen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Søren Jepsen, University Hospital, Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01917305
- Sponsor's protocol ID
- PFS3YRCT
- Status last verified
- Aug 2013
- First submitted
- 31 Jul 2013
- Last updated
- 9 Aug 2013
- Results posted
- No
Publications
Jervoe-Storm PM, Hablutzel AS, Bartels P, Kraus D, Jepsen S, Enkling N. Comparison of irrigation protocols for the internal decontamination of dental implants-results of in vitro and in vivo studies. Clin Oral Implants Res. 2021 Oct;32(10):1168-1175. doi: 10.1111/clr.13814. Epub 2021 Aug 27.
PubMed 34352143Enkling N, Johren P, Katsoulis J, Bayer S, Jervoe-Storm PM, Mericske-Stern R, Jepsen S. Influence of platform switching on bone-level alterations: a three-year randomized clinical trial. J Dent Res. 2013 Dec;92(12 Suppl):139S-45S. doi: 10.1177/0022034513504953. Epub 2013 Oct 24.
PubMed 24158333
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Platform-switching on Bone Level Alterations: a 3 Year RCT.
- ClinicalTrials.gov ID
- NCT01917305
- Acronym / sponsor ID
- PFS3YRCT
- Conditions
- Periimplant Crestal Bone Level Changes
- Keywords
- Bacteria, bone level, bone loss, dental implants, implant design, platform-shifting, platform-matching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Søren JepsenUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Mar 2010 (actual)
- First posted
- 6 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The concept of platform-switching has been introduced to implant dentistry based on clinical observations of reduced periimplant crestal bone loss. However, published available data are controversial and most studies are limited to 12 months. The aim of the present RCT was to test the hypothesis that platform-switching has a positive impact on crestal bone level changes after 3 years.
Detailed description
Two implants with a diameter of 4 mm were inserted crestally in the posterior mandible of 25 subjects. After three months of submerged healing, single-tooth crowns were randomly placed, either with (3.3mm platform, test) or without platform-switching (4mm platform, control). Patients were followed up at short intervals for monitoring of healing an oral hygiene. Statistical analysis for the influence of time and platform-type on bone levels employed the Brunner-Langer Model.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| platform-switched implant | Experimental | Device: platform-shifted implantplatform-switched implant |
| platform-matched implant | Active comparator | Device: platform-shifted implantplatform-matched implant |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- good general health
- edentulous gap in the posterior mandible for placement of 2 implants
- sufficient bone height above the alveolar nerve for placement of implants with a height of 9.5mm
- bone width for placement of implants with diameter of 4mm
- at least 4mm keratinized mucosa
Key exclusion criteria (5 listed)
- infectious disease
- diabetes or osteopathy
- active periodontitis
- medication influencing bone metabolism
- lactating or pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| platform-shifted implant | Device | platform-matched implant, platform-switched implant |
Primary outcome
Change of vertical implant bone level
Time frame: Implant insertion (baseline), 3 months (reopening), 4 months (crown mounting), 12, 25 and 38 months
3 secondary outcomes
probing depths
Time frame: 4, 8, 12, 25, 38 months
Bleeding
Time frame: baseline, 4, 8, 12, 25, 38 months
Plaque
Time frame: baseline, 4, 8, 12, 25, 38 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2013.
- Derived from this study: PubMed 34352143Jervoe-Storm PM, Hablutzel AS, Bartels P, Kraus D, Jepsen S, Enkling N. Comparison of irrigation protocols for the internal decontamination of dental implants-results of in vitro and in vivo studies. Clin Oral Implants Res. 2021 Oct;32(10):1168-1175. doi: 10.1111/clr.13814. Epub 2021 Aug 27.
- Derived from this study: PubMed 24158333Enkling N, Johren P, Katsoulis J, Bayer S, Jervoe-Storm PM, Mericske-Stern R, Jepsen S. Influence of platform switching on bone-level alterations: a three-year randomized clinical trial. J Dent Res. 2013 Dec;92(12 Suppl):139S-45S. doi: 10.1177/0022034513504953. Epub 2013 Oct 24.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing platform-shifted implant in people with Periimplant Crestal Bone Level Changes, run by Søren Jepsen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of vertical implant bone level (time frame: Implant insertion (baseline), 3 months (reopening), 4 months (crown mounting), 12, 25 and 38 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01917305, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2013.